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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

BD Alaris Pump Infusion Sets Recalled for Flow Rate and Accuracy Issues

Agency Publication Date: October 8, 2025
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Summary

CareFusion 303, Inc. (a BD company) is recalling various BD Alaris Pump Infusion Sets used with infusion pump modules. These sets may perform outside of their intended accuracy ranges, specifically regarding flow rate, bolus delivery, and the time it takes for the system to sound an alarm during a line blockage (occlusion). The manufacturer initiated this recall via letter on September 11, 2025.

Risk

If the infusion sets deliver medication at the wrong rate or fail to alarm when a line is blocked, patients may receive too much or too little medication. This can lead to serious injury or life-threatening complications, especially for patients receiving critical medications where precise dosing is required.

What You Should Do

  1. The recalled products are BD Alaris Pump Infusion Sets identified by several reference numbers, including C24101E, 10015414, 2447-0007, 24201-0007, 10012645, 2426-0500, 2450-0500, 11522558, 2410-0500, 2232-0007, 11613191, 10012144, 10013034, 10013037, and 11582773.
  2. Check the reference (REF) number and Unique Device Identifier (UDI) printed on the individual product packaging or shipping carton to determine if your sets are affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact CareFusion 303, Inc. or your equipment distributor to arrange for a return, replacement, or corrective action.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD Alaris Pump Infusion Setsby BD Alaris
Variants: Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site, 180 Micron Filter, Ball Valve SmartSite Port (Burette), Back Check Valve, Check Valve, 2 Ganged 3-Way Stopcocks, 2 Ganged 4-Way Stopcock, Non-Vented, Low Sorbing Tubing Segment
Model / REF:
C24101E
10015414
2447-0007
24201-0007
10012645
2426-0500
2450-0500
11522558
2410-0500
2232-0007
11613191
10012144
10013034
10013037
11582773
Lot Numbers:
All Lots
UDI:
10885403235528
10885403233999
10885403235078
10885403476341
10885403233753
7613203020992
10885403232305
7613203012492
10885403463969
10885403276026
7613203021159
10885403232312
10885403233784
10885403239588

Recall pertains to sets used with compatible pump infusion modules that may perform outside performance ranges for flow rate, bolus accuracy, and occlusion alarms.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97519
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Authorized Medical Distributors; Direct Sales
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.